SLIDE 13 New Clinical Trials Policy
13 NIH Definition of a Clinical Trial A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
- Applications/proposals involving clinical trials with due dates on or after January 25,
2018 must be submitted to a funding opportunity announcement (FOA) or request for proposal (RFP) that explicitly states it will accept clinical trials.
- All existing FOAs will be updated with the following changes:
- All clinical trial FOAs will specify allowability of clinical trials in the FOA title (required,
not allowed, optional)
- FOAs will specify the allowability of clinical trials in Section II. Award Information
- FOAs that accept clinical trials will incorporate specific review criteria to ensure that
reviewers appropriately consider clinical trial-related information
- https://grants.nih.gov/policy/clinical-trials/definition.htm
- K awards permit independent clinical trials – apply to the correct FOA
- T/F awards permit mentored ‘clinical trials research experience’ but not independent
clinical trials led by trainee or fellow
ORCD Achieving Research Independence, P. Kay Lund, PhD